# 2025-11030: VOYDEYA Patent-Extension Timeline Gets Official FDA Determination

2025-11030, Determination of Regulatory Review Period for Purposes of Patent Extension; VOYDEYA, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-16; PRIA reads it as touching household money (as of 2026-11-02).

- Canonical: https://policyrisk.com/federal-register/2025-11030
- As of: 2026-11-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-11030
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; VOYDEYA
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 25314
- Published: 2025-06-16
- Effective: unknown
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-11-02

## In one line

VOYDEYA Patent-Extension Timeline Gets Official FDA Determination

## Summary

The FDA has officially set the review period for VOYDEYA, a human drug, which helps the company extend its patent protection. If anyone thinks the dates are wrong, they can speak up by August 15, 2025, and questions about the company's effort during review can be raised by December 15, 2025. This means VOYDEYA’s makers might get more time to protect their invention, potentially affecting competition and market timing.

## Abstract

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VOYDEYA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

## Effects PRIA read

- FDA sets VOYDEYA review period length: benefit, high. FDA determined the regulatory review period for VOYDEYA is 2,355 days in total, consisting of a 1,989-day testing phase and a 366-day approval phase. The testing phase began with an investigational new drug effective date of October 19, 2017, the new drug application was submitted on March 30, 2023…
- Public comment and petition deadlines: benefit, low. Anyone who believes the published dates are incorrect may submit electronic or written comments and ask for a redetermination by August 15, 2025. Any interested person may petition FDA about whether the applicant acted with due diligence during the regulatory review period by December 15, 2025, usi…
- Applicant requests 1,358-day patent extension: benefit, high. In its application to the U.S. Patent and Trademark Office, the applicant for VOYDEYA (U.S. Patent No. 9,796,741) seeks 1,358 days of patent term extension. FDA notes that its determination establishes the maximum potential length of a patent extension, while the USPTO will apply statutory limitati…

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## Sources
- [2025-11030 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/16/2025-11030/determination-of-regulatory-review-period-for-purposes-of-patent-extension-voydeya)
- [2025-11030 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-11030.pdf)

## Related
- [Previous: 2025-11029, Determination of Regulatory Review Period for Purposes of Patent Extension; XOL…](https://policyrisk.com/federal-register/2025-11029)
- [Next: 2025-11031, Determination of Regulatory Review Period for Purposes of Patent Extension; VAF…](https://policyrisk.com/federal-register/2025-11031)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-11030 (as of 2026-11-02).